NA ETHMCS20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888551019088), received between Jul 19, 2018 and Dec 17, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2021Failure to Fire; Mechanical Jam; Failure to Fire; Mechanical Jam

  IT WAS REPORTED THAT A (B)(6), MALE, PATIENT UNDERWENT A LAPAROSCOPIC OPEN CHOLECYSTECTOMY PROCEDURE WITH FOUR REPROCESSED CLIP APPLIERS LIGACLIP AND DURING THE PROCEDURE, THE FOUR CLIP APPLIERS FAILED TO FIRE. A FIFTH CLIP WAS USED AND WORKED AS EXPECTED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025788 ↗
• MalfunctionApr 12, 2019Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH TWO MULTI CLIP APPLIER LIGACLIP SMALL CLIPS AND ONE MULTIPLE CLIP APPLIER LIGACLIP MCA AND ALL OF THE DEVICES HAS SCISSORING CLIPS. THE DEVICES WERE EXCHANGED TO COMPLETE THE PROCEDURE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT INJURY OR CONSEQUENCE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS REPORT IS FOR THE FIRST OF THE TWO MULTI CLIP APPLIER LIGACLIP SMALL CLIPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510434 ↗
• MalfunctionApr 12, 2019Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH TWO MULTI CLIP APPLIER LIGACLIP SMALL CLIPS AND ONE MULTIPLE CLIP APPLIER LIGACLIP MCA AND ALL OF THE DEVICES HAS SCISSORING CLIPS. THE DEVICES WERE EXCHANGED TO COMPLETE THE PROCEDURE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT INJURY OR CONSEQUENCE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS REPORT IS FOR THE SECOND OF THE TWO MULTI CLIP APPLIER LIGACLIP SMALL CLIPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510431 ↗
• InjuryJul 19, 2018Failure to Fire; Failure to Fire

  A USER FACILITY REPORT WAS RECEIVED FROM THE FDA THAT REPORTED A CLIP APPLICATOR WAS NOT FIRING PROPERLY AS THE CLIPS WERE NOT LOADING UP AND FIRING. IN ADDITION, ON THE USER FACILITY, THE EVENT TYPE OF SERIOUS INJURY WAS CHECKED AND EVENT OUTCOME OF REQUIRED INTERVENTION WAS ALSO CHECKED. HOWEVER, THERE WAS NO FURTHER INFORMATION ON THIS SERIOUS INJURY AS WELL AS NO CONTACT INFORMATION TO GAIN FURTHER CLARIFICATION. THEREFORE, TO BE CONSERVATIVE STERILMED IS REPORTING THIS EVENT AS A BLEEDING EVENT AS THAT IS OUR ASSUMPTION OF THE EVENT.

  Patient problems: Blood Loss

  MAUDE report 7705090 ↗